Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of Monograph for Over-the-Counter Nasal Decongestant Drug Products

摘要

The Food and Drug Administration (FDA) is proposing to amend the final monograph (FM) for over-the-counter (OTC) nasal decongestant drug products (drug products used to relieve nasal congestion due to a cold, hay fever, or other upper respiratory allergies) to add phenylephrine bitartrate as generally recognized as safe and effective (GRASE) when used in an effervescent tablet. An effervescent tablet is intended to be dissolved in water before taking by mouth. This proposal is part of FDA's ongoing review of OTC drug products.